Rehabilitation and Quality of Life in Residential Units for People With Longer Term Mental Health Problems
1 other identifier
interventional
240
1 country
1
Brief Summary
The study design is that of a cluster randomised controlled trial The aims of the study were: 1) to assess the quality of care of the residential units for people with long-term mental disorders; 2) to design a training intervention for the staff of the units in the intervention group; 3) to assess the effectiveness of the intervention 4 and 8 months after it ended. The main outcome variable was level of activity of the users. Secondary outcome variables were the QuIRC dimensions. The selection of the sample was by residential units for people with long-term mental disorders. The inclusion criteria were all the middle and high-support residential units in Portugal. Units that had only one type of service users (e.g., mental retardation, dementia) were excluded. The quality of care of the units was assessed with the QuIRC filled on line by the managers of the units and validated with Service Users Interview Schedule, a face-to-face interview with the users (users that could not give informed consent or collaborate in the interview were excluded).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 9, 2015
CompletedFirst Posted
Study publicly available on registry
February 19, 2015
CompletedFebruary 19, 2015
February 1, 2015
2.8 years
February 9, 2015
February 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of time spent in any activity during a week by patients
The percentage of time spent will be measured by the "Time Use Diary" instrument.
Four months
Study Arms (2)
Training
EXPERIMENTALData collected during the first pahse of the study will be presented and discussed in a specialist focus group, which will work with the study team as advisors and trainers, to decide on the type of training to be developed. This training intervention will be applied to the facilities presenting half the patient sample size.
No Training
NO INTERVENTIONFacilities representing half the sample size will not be trained as in the Experimental Arm and continue their standard of care for these patients.
Interventions
Adapted training on the patients active participation, rehabilitation, independence, rights and wellbeing.
Eligibility Criteria
You may qualify if:
- Mental Health Problems
You may not qualify if:
- Refusal to enter the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Nova de Lisboalead
- Direção Geral de Saúdecollaborator
Study Sites (1)
Faculdade de Ciências Médicas
Lisbon, Lisbon District, 1169-056, Portugal
Related Publications (1)
Cardoso G, Papoila A, Tome G, Killaspy H, King M, Caldas-de-Almeida JM. A cluster randomised controlled trial of a staff-training intervention in residential units for people with long-term mental illness in Portugal: the PromQual trial. Soc Psychiatry Psychiatr Epidemiol. 2017 Nov;52(11):1435-1445. doi: 10.1007/s00127-017-1416-7. Epub 2017 Jun 30.
PMID: 28667486DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2015
First Posted
February 19, 2015
Study Start
April 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
February 19, 2015
Record last verified: 2015-02